Updates on the EU:
German DPA Publishes First Privacy Shield Guidelines, Requires German-Law Contracts for Transfers. On June 7, 2016, the European Commission adopted the EU-U.S. Privacy Shield. One question that many...more

On November 3, 2016, the US Court of Appeals for the Second Circuit approved an injunction against about 200 importers and sellers preventing them from importing and selling gray market blood-glucose test strips. The case was...more

We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also...more

Earlier this month a proposed class action was filed in Montreal by the Consumer Law Group alleging that Merck, Shering-Plough and Daiichi Sankyo (the Defendants) provided inadequate warnings about the drugs Olmetec and...more

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more

This week’s election of Donald Trump as the next President of the United States undoubtedly impacts many sectors of the American economy, and the bio/pharmaceutical industry is no exception. Two of Trump’s stated policies...more

The Obama Administration made significant new regulatory changes to allow certain investment opportunities in the Cuban health care and biotech industries. While many barriers remain, US firms in the health care industry...more

According to The Korea Herald, the South Korean biopharma company Celltrion submitted their Herceptin biosimilar, Herzuma, to the European Medicine Agency for approval. Herzuma, a biosimilar to Roche’s breast cancer drug...more

The Irish Times reports that Pfizer will be cutting the price of Enbrel® (etanercept) on November 1st.
Pfizer is cutting its price to comply with Ireland’s Framework Agreement on the Supply and Pricing of Medicines (the...more

On October 14, 2016, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of Commerce’s Bureau of Industry and Security (BIS) announced further amendments to ease U.S. sanctions and...more

On 19 October 2016, the Court of Justice of the European Union (CJEU) issued an important judgment concerning the German law on fixing prices of retail prescription drugs.
In the case before the Higher Regional Court of...more

EU law precludes national legislation setting fixed retail prices for prescription medicinal products, as it unreasonably restricts imports -
On 19 October 2016, the European Court of Justice issued a ruling concluding...more

The SEC finished with the last nail in GSK China’s coffin by announcing a $20 FCPA million settlement for GSK’s violations in China.
The Justice Department declined to prosecute this case. In 2014, a Chinese court...more

Last week a true American original died when Richard Trentlage passed away. If you do not know his name you certainly know signature contribution to American culture, the Oscar Meyer Weiner Song. Rather amazingly Trentlage...more

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

Hacking group Fancy Bear, reportedly a Russian group, who allegedly hacked into the Democratic National Committee emails which made headlines, has posted U.S. Olympians’ medical and drug testing records online. Although it...more

According to Business Wire, on September 12, 2016, Samsung Bioepis announced that it has added Canada to its growing list of jurisdictions in which it has received regulatory approval for its biosimilar of Amgen’s Enbrel®...more

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

Last week, the SEC added another pharmaceutical company to its list of FCPA violators when AstraZeneca agreed to a $5.5 million settlement with the SEC. AZ is now the 25th drug or medical device company to pay an FCPA penalty...more

Spotlight on the False Claims Act -
Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

The European Food Safety Authority (EFSA) requested a review of the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors. The results of the review are published in the August 2016...more

InSeal Medical recently announced that it has received CE Mark approval for its InClosure large bore vascular closure device (VCD). The InSeal VCD provides an internal biodegradable membrane for sealing large cuts in blood...more

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Privacy Policy (Updated: October 8, 2015):

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